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Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI) (NB-SCI)

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ClinicalTrials.gov Identifier: NCT02559804
Recruitment Status : Unknown
Verified July 2016 by Associazione Italiana Ematologia Oncologia Pediatrica.
Recruitment status was:  Recruiting
First Posted : September 24, 2015
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Istituto Giannina Gaslini
Information provided by (Responsible Party):
Associazione Italiana Ematologia Oncologia Pediatrica

Brief Summary:
To describe the natural history of peripheral neuroblastic tumour presenting with SCI and evaluate the combined effects of different risk factors on the eventual neurologic and orthopaedic outcomes

Condition or disease Intervention/treatment
Neuroblastic Tumors Other: survival and late effects

Detailed Description:

Multi-centre, observational, prospective study registry. About 15% of patients with peripheral neuroblastic tumour present with extradural SCI, of whom approximately 60% are symptomatic. Since SCI may progress to irreversible paraplegia, early diagnosis and prompt treatment is of critical importance.1-3 The treatment options include chemotherapy, neurosurgical decompression and radiation therapy. All may relieve epidural compression, but there is no consensus on which to use first in the individual patient. However, the choice of the treatment could be relevant in the perspective of reducing to the minimum the risk of long-term sequelae.4 Guidelines for the diagnostic work-up and treatment of SCI for International Society of Paediatric Oncology European Neuroblastoma (SIOPEN) neuroblastoma patients were already available in the "guidelines for the treatment of patients with localized resectable neuroblastoma and analysis of prognostic factors" (LNESG1 Protocol), back in 1994,5 although it is unknown how they were applied in the SIOPEN Centres. These guidelines have been reformulated in occasion of the recently activated "European Low and Intermediate risk Neuroblastoma" (LINES Protocol).

There are few publications addressing the diagnosis and treatment of SCI; most are retrospective studies, case reports, or reviews that may be affected by reporting bias.1-9 Therefore new guidelines could be designed based on the information derived from a prospective data collection of newly diagnosed patients.

For this study Spinal Canal Involvement (SCI) is defined when, referring to an axial plane of the spinal cord MRI scan (Figure 1), the tumour extends into the vertebral canal and goes beyond a mentally drown ellipsoid (red circle) passing through the cortical bone of both anterior and posterior arches of the vertebra. This involvement is called "intraspinal" or, better, "intracanal".

Patient data to be collected and included in the corresponding Forms

  1. work-up at diagnosis, including radiology report (Computed Tomography or Magnetic Resonance Imaging)
  2. treatment administered
  3. response to treatment, including radiology report
  4. follow-up
  5. outcome

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
Study Start Date : May 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Group/Cohort Intervention/treatment
patients NB with SCI
Survival and late effects. Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression).
Other: survival and late effects
survival and late effects




Primary Outcome Measures :
  1. prevalence of neurologic consequences [ Time Frame: for 5 years ]
    American Spinal Injury Association ASIA impairment scale

  2. prevalence of orthopedic consequences [ Time Frame: for 5 years ]
    using Common Terminology Criteria for Adverse Events v. 4.0

  3. prevalence of pain [ Time Frame: for 5 years ]
    using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)


Secondary Outcome Measures :
  1. relapse or second tumour [ Time Frame: 5 years ]
    event free survival

  2. survival [ Time Frame: 5 years ]
    overall survival



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in the age range 0-18 years diagnosed with peripheral neuroblastic tumour and SCI in the period from May 2014 to April 2017
Criteria

Inclusion Criteria:

  • Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression)
  • No previous chemotherapy, except steroids, in the last 6 months
  • Age <18 years
  • Minimal planned follow-up of 5 years
  • Parent/patient written informed consent (Appendix 1(A,B,C))

Exclusion Criteria:

  • Invasion of intervertebral foramina only

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559804


Contacts
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Contact: Riccardo Haupt, MD 01056363462 ext +39 riccardohaupt@ospedale-gaslini.ge.it
Contact: tiziana landi 051/2144667 ext +39 segreteria@aieop.org

Locations
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Italy
Istituto Giannina Gaslini Recruiting
Genova, Italy, 16147
Contact: Riccardo Haupt, MD    01056363462    riccardohaupt@ospedale-gaslini.ge.it   
Contact: Stefania Sorrentino       stefaniasorrentino@ospedale-gaslini.ge.it   
Sponsors and Collaborators
Associazione Italiana Ematologia Oncologia Pediatrica
Istituto Giannina Gaslini
Investigators
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Principal Investigator: Riccardo Haupt, MD Istituto Giannina Gaslini Genova

Additional Information:

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Responsible Party: Associazione Italiana Ematologia Oncologia Pediatrica
ClinicalTrials.gov Identifier: NCT02559804     History of Changes
Other Study ID Numbers: NB with SCI
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: July 2016